NCT02872467

Brief Summary

The purpose of this research is to study the effects of nasal oxytocin administration on maternal behaviors that may be influenced by cocaine use during pregnancy. 32 mothers with prenatal use of cocaine during the current pregnancy will be studied at 3-6 months postpartum, when they will complete 3 study visits, a 2-week double-blind trial of twice daily nasal spray (oxytocin or placebo) and 4 telephone interviews. All information collected is confidential.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 18, 2023

Status Verified

February 1, 2022

Enrollment Period

6.8 years

First QC Date

July 12, 2016

Last Update Submit

April 14, 2023

Conditions

Substance Abuse ProblemPregnancy

Keywords

CocaineMothersPregnant womenPostpartum womenOxytocinSubstance use disordersSubstance abusePrenatal substance usestress

Outcome Measures

Primary Outcomes (1)

  • The effects of a 2-week trial of twice nasal oxytocin compared with placebo on maternal sensitivity

    2 weeks

Secondary Outcomes (3)

  • The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in vascular resistance from pre- to post-test nasal spray.

    2 weeks

  • The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by change in plasma norepinephrine.

    2 weeks

  • The effects of a 2-week trial of nasal oxytocin compared with placebo on maternal reactivity to a social stressor indexed by self-reported affective ratings.

    2 weeks

Study Arms (2)

Syntocinon treatment

EXPERIMENTAL

Syntocinon spray, 24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).

Drug: Syntocinon treatment

Placebo

PLACEBO COMPARATOR

Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.

Other: Placebo

Interventions

Syntocinon treatmentDRUG

24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).

Also known as: Nasal Oxytocin treatment
Syntocinon treatment
PlaceboOTHER

Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.

Placebo

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • months postpartum at start of testing
  • Cocaine use during current pregnancy (by self-report or medical record of prenatal urine toxicology)
  • Exclusive Formula-feeding for all infant milk feedings (no infant feeds will be breast milk)
  • Healthy singleton pregnancy
  • English fluency that will allow informed consent

You may not qualify if:

  • Pregnancy or plans to become pregnant during participation in the study
  • Not using effective birth control methods to prevent pregnancy
  • Breastfeeding for any infant milk feedings
  • Mother is not currently living with the infant during the trial period
  • Multiple birth (twin, triplet or greater)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC School of Medicine, Medical School Wing D

Chapel Hill, North Carolina, 27599-7175, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Karen Grewen, Ph.D.

    UNC School of Medicine, Dept. of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

August 19, 2016

Study Start

May 1, 2016

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

April 18, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)